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510(k) K811404

TRAVELAIRE by B & F Medical Products, Inc. — Product Code CCQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1981
Date Received
May 18, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Device Class
Class I
Regulation Number
868.5640
Review Panel
AN
Submission Type

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  • K913501 — TRACHEOSTOMY MASK (January 13, 1992)
  • K861325 — MAXI-USE O2 DEVICE (September 9, 1986)
  • K861054 — DISPOSABLE RESCUE BREATHING DEVICE (April 9, 1986)
  • K853004 — PORTABLE OXYGEN UNIT (August 29, 1985)
  • K843691 — PORTABLE OXYGEN UNIT (November 7, 1984)
  • K823532 — STOCK #64091-PEDIATRIC OXYGEN MASK (January 5, 1983)
  • K802644 — EMERG. OXYGEN KIT #65350 & #65399 CASE (December 22, 1980)
  • K802646 — HAND PERCUSSOR CUP #65210 (November 12, 1980)

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  • K895115 — FRANK INHALER THERMAL S (May 18, 1990)
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